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New treatment option for Multiple Myeloma in Relapse
Official title Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse
ClinicalTrials.gov ID: NCT06827860
What this study is testing
What is Talquetamab?
Talquetamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple myeloma in relapse.
Also referred to as JNJ-64407564.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Induction therapy approaches in recent years have evolved, now utilizing triple or quadruple drug regimens in the majority of patients. By combining anti-CD38 antibodies, proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and steroids, patients achieve longer remissions with their first- and second-line therapies but also become refractory to most or all three major drug classes earlier.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 70 and older
You may be able to join if
- Documented multiple myeloma as defined by the criteria below:
- Multiple myeloma diagnosis according to the IMWG diagnostic criteria
- Measurable disease at screening as assessed by central laboratory, defined by at least 1 of the following:
- Serum M-protein level ≥0.5 g/dL (central laboratory)
- Urine M-protein level ≥200 mg/24 hours (central laboratory)
You likely can't join if
- Any potential subject who meets any of the following criteria will be excluded from participating in the study:
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the talquetamab and...
- Prior treatment with T-cell-engaging antibodies
- Prior antitumor therapy as follows, prior to the first dose of study drug: o Any prior GPRC5D-directed therapy
- Gene-modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells) within 3 months
- Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or at...
See the full eligibility criteria
Who can join
- Documented multiple myeloma as defined by the criteria below:
- Multiple myeloma diagnosis according to the IMWG diagnostic criteria
- Measurable disease at screening as assessed by central laboratory, defined by at least 1 of the following:
- Serum M-protein level ≥0.5 g/dL (central laboratory)
- Urine M-protein level ≥200 mg/24 hours (central laboratory)
- Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain ≥10 mg/dL or \>100 mg/L (central laboratory) provided the serum free light chain ratio is...
- Relapsed or refractory disease as defined below:
- Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria \>60 days after cessation of treatment.
- Refractory disease is defined as \<25% reduction in M-protein or confirmed progressive disease by IMWG criteria during previous treatment or ≤60 days after cessation of treatment. Received at least 1 prior line(s) of...
- Subject must have received at least ≥2 prior line(s) of systemic antimyeloma therapy of treating physician's discretion, including a PI and an IMID
- people who are anti-CD38 monoclonal antibody-naïve, exposed, or refractory will be allowed in Part 1; Only people who are anti-CD38 antibody-naïve or exposed will be allowed in Part 2, whereas people refractory to...
- Have clinical laboratory values meeting the following criteria during the Screening Phase: Hematology Hemoglobin: ≥7 g/dL (≥4.96 mmol/L; without transfusion support or erythropoietin use within 7 days before the...
- Human immunodeficiency virus-positive participants are eligible if they meet all of the following:
- No detectable viral load (ie, \<50 copies/mL) at screening
- CD4+ count \>300 cells/mm3 at screening
- No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 6 months of screening
- Receiving HAART. Any changes in HAART due to resistance/progression should occur at least 3 months prior to screening. A change in HAART due to toxicity is allowed up to 4 weeks prior to screening. Note: HAART that...
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 100 days after receiving the last dose of study treatment.
- Must be willing and able to adhere to the prohibitions and restrictions specified in this protocol (Section 2, including to not donate blood or blood components during the study and for 100 days after the last dose of...
- Sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to and able to participate in the study. Consent is to be obtained prior to...
What rules you out
- Any potential subject who meets any of the following criteria will be excluded from participating in the study:
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the talquetamab and daratumumab Investigator's Brochure and appropriate prescribing...
- Prior treatment with T-cell-engaging antibodies
- Prior antitumor therapy as follows, prior to the first dose of study drug: o Any prior GPRC5D-directed therapy
- Gene-modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells) within 3 months
- Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less.
- Investigational vaccine other than SARS CoV-2 vaccine approved/ in use under emergency approval within 4 weeks o Live, attenuated vaccine within 4 weeks
- Monoclonal antibody treatment for multiple myeloma within 21 days.
- Cytotoxic therapy within 21 days.
- Proteasome inhibitor therapy within 14 days. o Immunomodulatory agent therapy within 14 days. o Radiotherapy within 14 days or focal radiation within 7 days
- Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.
- Received a maximum cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14-day period before the first dose of study drug.
- Stem cell transplantation:
- Previous allogenic stem cell transplant
- Received an autologous stem cell transplant ≤12 weeks before the first dose of study drug
- Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required.
- Plasma cell leukemia (\>20% circulating plasma cells and/or \>2.0 x 109/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal...
- Myelodysplastic syndrome or active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than relapsed/refractory multiple myeloma. The only allowed exceptions are: o Non-muscle...
- Noninvasive cervical cancer treated within the last 24 months that is considered completely cured
- Localized prostate cancer (N0M0): \- With a Gleason score of ≤6, treated within the last 24 months, or untreated and under surveillance
- With a Gleason score of 3+4 that has been treated \>6 months prior to full study screening and considered to have a very low risk of recurrence, or
- History of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence
- Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence
- Other malignancy that is considered cured with minimal risk of recurrence.
- Stroke or seizure within 6 months prior to signing ICF.
- Any of the following:
- Active Hepatitis B infection (ie, HBsAg or HBV-DNA positive). In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status see Section Hepatitis B Virus Testing...
- Active hepatitis C infection as measured by positive HCV-RNA testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic hepatitis C infection...
- Any concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this...
- Uncontrolled diabetes o Acute diffuse infiltrative pulmonary disease
- Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic antimicrobial therapy within 7 days of start of study treatment
- Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment. EXCEPTION: Participants with vitiligo, controlled type I diabetes, and prior autoimmune thyroiditis...
- Disabling psychiatric conditions (e.g., alcohol or drug abuse), severe dementia, or altered mental status
- Any other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the...
- History of non-compliance with recommended medical treatments Plans to father a child while enrolled in this study or within 100 days after the last dose of study drug.
- Presence of the following cardiac conditions:
- New York Heart Association stage III or IV congestive heart failure
- Myocardial infarction or coronary artery bypass graft ≤6 months prior to randomization
- Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities
- History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration o History of severe non-ischemic cardiomyopathy Major surgery within 2 weeks...
- NOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery. If there is a question whether a procedure is...
- Known moderate of persistent asthma within the past 2 years or currently has uncontrolled asthma of any classification. Note: Participants who currently have controlled intermittent asthma or controlled mild persistent...
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 70 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.